December 16, 2009
Swine Flu Shots For Kids Recalled, Lost Potency
Government health officials say that over 800,000 swine flu shots for kids have been recalled due to the vaccine losing its potency.
According to the Centers for Disease Control and Prevention, the shots were distributed across the country last month and many have already been used. The recalled vaccine was for ages 6 months to 3 years.
"The vaccine is safe and effective," she said.
When the vaccine was first shipped, tests showed the shot was strong enough. But weeks later, tests show the strength had fallen slightly below required levels.
The reason for the drop in potency is unknown. Len Lavenda, a spokesperson for Sanofi Pasteur, said, "That's the $64,000 question."
Schuchat said young children are supposed to get two doses, spaced about a month apart. Health officials don't think children need to get vaccinated again, even if they got two doses from the recalled lots.
There's been about 95 million doses of the vaccine distributed over the U.S. since it was released in early October.
The recalled shots, made by Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group, were tested last week and scientists found the potency level had fallen 12 percent below the government standard.
The company found three other lots with diminished strength. It notified government health officials and did a voluntary recall, asking doctors to return any unused doses. The vaccine has been in high demand and the company doesn't expect to see much come back, Lavenda said.
Lavenda added officials with the Food and Drug Administration and the CDC believe the vaccine is still strong enough to protect against the virus. No potency problem has been detected in the same vaccine packaged in other types of syringes or vials.
Dr. Jesse Goodman, the FDA's deputy commissioner for science and public health, believes the problem may lie in the pre-filled syringes. For some reason, the antigen -- the key ingredient -- may be sticking to the walls of the syringes.
In February, another manufacturer, Novartis, recalled five lots of seasonal flu vaccine packed in pre-filled syringes under similar circumstances.
Sanofi Pasteur bills itself as the No. 1 manufacturer of flu vaccines in the world. It makes flu vaccine at sites in France and in Pennsylvania.
Swine flu was first identified in April. During the first seven months of the pandemic, it has sickened about 50 million Americans and killed about 10,000, according to CDC estimates.
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